Unichem Labs' Kolhapur API Facility Gets 5 USFDA Observations
Written By : Parthika Patel
Published On 2026-02-04 15:00 GMT | Update On 2026-02-04 15:00 GMT
Advertisement
New Delhi: Unichem Laboratories Limited has informed that the United States Food and Drug Administration (USFDA) has concluded an inspection of the company's Kolhapur active pharmaceutical ingredient (API) manufacturing facility with five observations, all of which were procedural in nature and not related to data integrity.
In a regulatory filing dated February 2, 2026, Unichem Laboratories Limited stated that the USFDA carried out the inspection at its Kolhapur API facility from January 27, 2026, to February 2, 2026. The inspection closed with five observations, which the company clarified were mainly linked to procedural aspects.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.